Nordic Pharma's Canalicular Gel Lacrifill Receives CE Mark for Dry Eye Disease Treatment
Key Insights
Nordic Pharma (search) has received CE Mark approval in the European Union for Lacrifill (search), a cross-linked hyaluronic acid gel that temporarily blocks tear drainage by occluding the canalicular system (search).
The innovative treatment offers a single in-office procedure with effects lasting up to 6 months, addressing a condition that affects approximately 30% of the European population.
Lacrifill (search), which previously received U.S. approval in June 2024, demonstrated promising results in a pilot study where 83% of participants experienced no pain and 63% reported improved eye comfort after treatment.
Nordic Pharma (search) announced that its canalicular gel Lacrifill (search) has received CE Mark approval in the European Union several months ahead of schedule. The treatment, designed specifically for dry eye disease (search), works by temporarily blocking tear drainage through occlusion of the canalicular system (search).
The cross-linked hyaluronic acid gel preserves the eye's natural tears, offering patients an individualized approach to managing dry eye symptoms. According to the company, a single in-office procedure provides a complete fill of the canalicular system (search) with effects that may last up to six months.
"Receiving CE mark approval for Lacrifill (search) is an important milestone for Nordic Pharma (search) and adds to our commitment to innovative ophthalmic therapies in Europe," said Charlotte Phelps, CEO of Nordic Group B.V. "We are excited to bring this novel dry eye solution to patients and healthcare professionals across Europe and look forward to the upcoming launch."
Clinical Significance and Market Impact
Dry eye disease (search) represents a significant health burden, affecting approximately 30% of the European population. Recent research has confirmed both the prevalence of the condition and its substantial impact on patients' quality of life. Management becomes particularly challenging when dry eye occurs alongside other ocular pathologies or following procedures such as cataract surgery and LASIK.
Nordic Pharma (search), headquartered in France and the Netherlands, is now preparing for a commercial rollout of Lacrifill (search) in select European markets. The company has indicated that details regarding commercialization and product availability will be announced as the launch date approaches.
Clinical Evidence Supporting Efficacy
Lacrifill (search) previously received approval in the United States in June 2024. The regulatory decision followed a proof-of-concept pilot study involving 63 patients with dry eye disease (search). The clinical investigation yielded promising results:
- 83% of participants experienced no pain
- 94% of participants had no infections
- 63% reported that their eyes felt better after treatment
The treatment's mechanism of action differs from traditional approaches to dry eye management by focusing on tear retention rather than solely on tear production or inflammation control. By occluding the tear drainage system, Lacrifill (search) helps maintain natural tear film on the ocular surface.
Treatment Administration and Patient Experience
The Lacrifill (search) procedure is performed in a clinical setting and does not require surgery. The hyaluronic acid gel is carefully administered to occlude the canalicular system (search), which helps preserve tears naturally produced by the eye. This approach may be particularly beneficial for patients who have not responded adequately to artificial tears or other conventional treatments.
As Nordic Pharma (search) moves forward with European commercialization plans, the treatment could represent an important addition to the therapeutic arsenal for ophthalmologists treating the millions of Europeans affected by dry eye disease (search).